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The key symptom of COPD is breathlessness, especially during daily activity, and the breathlessness is in addition to cough and chest tightness.

The difficulty in managing this disease is that it's a disease that progresses with age. So far, we haven't found any cure or way of improving the disease, especially at later disease stages. We can only ameliorate the disease progression with pharmaceutical intervention.

The only thing that has shown to improve outcomes is rehabilitation, which is not widely available, and smoking cessation, which many patients struggle with. That's why there is an unmet need for additional management options.

Essentially, home NIV was developed in the 60s and 70s when there was also an unmet need for patients suffering from post-polio syndrome. There was a polio epidemic in Europe and there were many patients who needed intubation and prolonged mechanical ventilation, to be able to survive. The problem with that was that there was not enough capacity to take care of all the patients, so technologies were developed to treat them with prolonged ventilation and that’s where I think intubation really started.

Although there was also some earlier home mechanical ventilation (HMV) treatment, it was not really the mechanical ventilation as we know it today. There was the iron lung, which was used before modern ventilation was developed.

The real rise in HMV started in 1980/1981, when continuous positive airway pressure treatment of obstructed sleep apnea was invented. That drove a whole industry in terms of positive airway pressure and mask technology which could not only be used for treating obstructive sleep apnea but also for managing patients on HMV. That was really the main game changer for HMV.

Lumis 150 VPAP ST-A Home NIV device from ResMed

So far, home NIV has mainly been used in a very small proportion of patients, which is mainly neuromuscular patients. For example, patients with muscular dystrophy. They may be children or adults, but I think that's been the main target group in most countries.

There have been a few patients who were already being treated for COPD, but really only a few. The other main use of it was for the patients suffering from other disease, such as a skeletal problem like scoliosis. Of course, in recent years there has also been a certain rise in home patient ventilation infusion in patients suffering from respiratory problems as a result of being obese.

In COPD, care practices have differed between European countries, but in some countries, such as Germany and France, there has already been an increase in users and the need for research.

There are two different phenotypes of COPD. For one, the main problem is oxygenation. Most are emphysema-type illnesses where the problem is getting enough oxygen in. The other phenotype is a problem with getting enough air out and, with that, getting enough carbon dioxide out. Patients with this phenotype are referred to as hypercapnic patients. Those are the two distinct phenotypes, which warrant different management.

What we've always known is that if a hypercapnic patient comes to hospital and is in acute crisis, we can use HMV or the technology that has also been used in HMV, which is NIV, to save lives. It takes eight patients to be treated, for one life to be saved, so it's a highly effective treatment in the hospital.

In the late 2000s, a group wanted to answer the question of whether patient outcomes can be improved by using ventilation at home after an acute event, with enough timing between for the patient to stabilize, which is just prolonged management of the patient with NIV. That was essentially the question; or whether just treating a patient with oxygen was good enough.

Stellar 150 Home NIV device from ResMed

The study showed that the patients had to wait at least two weeks after they had an acute event in a hospital and required non-invasive ventilation NIV. After those two weeks, they were referred back to the hospital and checked to see if they were still hypercapnic. If so, they were randomized to either oxygen or, in addition, HMV.

The investigators looked at improving hospital-free survival, so the patient either spent a longer time at home before going back to the hospital or they spent a longer time alive. They found a massive risk reduction in terms of hospital-free survival when NIV was used.

I think people were impressed by the results and by the magnitude of the results. This study confirms results from a German study published the year before that people were quite skeptical about and didn’t really believe.

This second study, confirming that the use of HMV can improve outcomes in hypercapnic COPD patients, is really a game changer. This will really change practice and since there have not been any treatments for these COPD patients, I think everybody is impressed by the idea of them being able to do this.

I think this will lead to a much wider use of home NIV throughout Europe and also throughout other countries. I think it's important that we use medical education so that people understand the results and what the results mean for clinical practice and the patient.

Medical education will also be required because people, especially pulmonologists, will need to learn the practice of using home NIV in a specific patient group, which is also a little bit more challenging than using it for neuromuscular patients. I think we will see a definite increase in the use of it.

LifeChoice Activox 4L Portable Oxygen Concentrator from ResMed

I think the future goal is what we call precision medicine. We're trying to better phenotype patients and find targeted treatment for the right patients while also engaging patients actively in their disease management.

As we can already see, there are two phenotypes: the hypercapnic and the hypoxic patients. The hypercapnic phenotype is a target for ventilation. For the hypoxic phenotype, there is research that should come out in a couple of weeks about oxygen therapy and that's something that is also important for providing portable oxygen concentrators. That is key because I think with all the interventions, what we shouldn't forget is that we need those patients to get more daily activity, which is difficult. Providing ventilation can help them change, become more active and improve their outcomes.

Our plan at ResMed is to provide, on the one hand, the technology for ventilators and oxygen, but also we're getting more and more into connected care and trying to provide solutions to healthcare providers and physicians that will essentially ease the management of these patients and also engage the patients with their treatment and treatment management plan.

What we shouldn't forget is that, in addition to HMV, there's a large proportion of patients suffering from obstructive sleep apnea in the COPD patient group. Another target ResMed has, is that even if those people don't have respiratory failure, they are identified for obstructive sleep apnea because that can also improve quality of life and increase daily activity, which again is important for improving disease progression in these patients.

Perhaps a final point is that the future of COPD management is one of the most thrilling areas in medicine at the moment because currently we're talking about subjective assessments of patients such as how they use their inhalation therapy and oxygen, but with connected care, which is essentially telehealth, ehealth, mhealth and so on, I think in the next 5-10 years, we'll get objective information about how people use their therapies like their ventilators and oxygen, but also their inhalers and how this affects their daily activity.

With the use of smart inhalers that pharma should be introducing in the next 5 years to also assess the quality of pharmaceutical therapy, and with the use of modern actigraphy and other wearable sensors, we'll be able to monitor the disease state and health status of these patients.

I think, essentially, it's going to move from subjective management of patients and finally get them into objective management, which I think will transform medicine and make it better and more tailored to the patient group.

He was at the University Hospital Ulm till 2006. He is a consultant in the lung center Ulm and heads up their sleep and ventilation center in Balubeuren, Germany.

Since 2006 he is working for ResMed and is responsible for clinical research and for Medical Affairs in EMEA and APAC (VP Clinical Research and Medical Director of EMEA/APAC).

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Posted in: Insights from Industry | Device / Technology News | Medical Condition News

Tags: Children, Cough, Education, Emphysema, Healthcare, Hospital, L.L., Lungs, Medicine, Muscular Dystrophy, Obstructive Sleep Apnea, Oxygen, Oxygen Therapy, Pharmaceuticals, Phenotype, Polio, Post Polio Syndrome, Precision Medicine, Research, Respiratory, Scoliosis, Sleep, Sleep Apnea, Smoking, Smoking Cessation

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